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Fully Automatic Platelet Aggregometer - NMPA Registration 京械注准20252220005

Access comprehensive regulatory information for Fully Automatic Platelet Aggregometer in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20252220005 and owned by Beijing Lepu Medical Technology Co., Ltd.. The device was approved on January 02, 2025.

This page provides complete registration details including registrant information, province location (Beijing), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

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Class II
京械注准20252220005
Fully Automatic Platelet Aggregometer
全自动血小板聚集仪
NMPA Registration Number: 京械注准20252220005
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DJ Fang

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Pricing
Intended Use
English

与北京乐普诊断科技股份有限公司生产的试剂配套使用,适用于血小板聚集率的检测。

Device Classification
Device Class
Class II
Model Specifications
LEPUFR2000
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20252220005
Approval Date
January 02, 2025
Expiry Date
January 01, 2030
Registrant
Name
Beijing Lepu Medical Technology Co., Ltd.
北京乐普诊断科技股份有限公司
Province/Region
Beijing
北京
Address
No. 37, Chaoqian Road, Science and Technology Park, Changping District, Beijing
北京市昌平区科技园区超前路37号
Production Facility
Production Address
烟台开发区南京大街10号1#厂房1层1101、2层-5层,2#厂房
Structure and Composition
English

全自动血小板聚集仪由检测模块、液路模块、显示触摸模块、电气控制模块、样品杯和样品杯架、和随机软件(发布版本号:1)组成。

Storage Conditions and Expiration
English

10 years

中文

10年

Additional Information
Remark
受托生产企业:烟台艾德康生物科技有限公司;统一社会信用代码:91370600791536775R
Appendix
产品技术要求